ATTAIN CLARITY™
GUDID 00643169181717
Balloon Catheter 6225 Attain Clarity
MEDTRONIC, INC.
Cardiac ventriculography catheter Cardiac ventriculography catheter| Primary Device ID | 00643169181717 |
| NIH Device Record Key | 20c60478-ca94-4dae-bdee-e31104f50040 |
| Commercial Distribution Discontinuation | 2018-05-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ATTAIN CLARITY™ |
| Version Model Number | 6225 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169181717 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121219
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-11 |
On-Brand Devices [ATTAIN CLARITY™]
| 00643169530102 | Balloon Catheter 6225 Attain Clarity |
| 00643169181717 | Balloon Catheter 6225 Attain Clarity |
Trademark Results [ATTAIN CLARITY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ATTAIN CLARITY 85431924 4614134 Live/Registered |
Medtronic, Inc. 2011-09-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.